On January 28, 2020, an Agreement from the Mexican Comisión Federal para la Protección Contra Riesgos Sanitarios (COFEPRIS) was published in the Mexican Official Gazette. This Agreement recognizes the requirements and procedures authorized by the reference health authorities, as equivalent for the purposes of evaluation of the marketing authorization process for allopathic medicinal products, biological medicinal products, vaccines and blood products in Mexico. The agreement is only applicable to drug products which are needed in national territory, however are not available due to quality or shortage reasons. They will only be imported for distribution by public health entities. (updated 18th March)

This Agreement is called “Agreement by which the requirements established in articles 161 bis, 167, 169, 170 and 177 of the Regulation on Health Supplies and the technical evaluation procedures carried out by the Comisión Federal para la Protección contra Riesgos Sanitarios for granting the marketing authorization of the health supplies referred to in articles 2, fractions XIV, XV, items B and C, and 166, fractions I, II and III of the Health Supplies Regulation; in relation to articles 222 and 229 of the General Health Law, the requirements requested and assessment procedures carried out; as well as the importation of medicinal products with or without marketing authorization in Mexico, for any disease or condition, which are authorized by the following regulatory authorities: Swiss Agency for Therapeutic Products – SWISSMED, European Commission, Food and Drug Administration of the United States of America , Canadian Ministry of Health, Australian Therapeutic Goods Administration, PAHO / WHO reference regulatory agencies prequalified by the World Health Organization Prequalification Program for Drugs and Vaccines or regulatory agencies members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S)”* .

The companies must request the marketing authorization through the forms defined by the Department of Health. The requests must include the following documentation, in addition to the document that proves the reference marketing authorization, in CTD format and in Spanish (always accompanied by the original documents in foreign language):

• Identity and purity of its components according to the Mexican Pharmacopoeia;

• Stability of the finished product according to current regulations;

• Efficacy and safety studies;

• Complete and reduced prescription information;

• Labeling and package artwork projects;

• Primary and secondary packaging specifications;

• Brand name (denominación distintiva);

• Certificates of Good Manufacturing Practices (GMP) for active pharmaceutical ingredients (APIs) and finished product, issued by COFEPRIS or by recognized authorities in terms of GMP certification (PIC/S). It is important to mention that the packaging process is considered as part of the manufacturing process;

• Mexico patent documentation;

• Interchangeability studies for generic drugs that require a bioequivalence study as evidence of such;

• Positive opinion from the Committee of New Molecules, for vaccines and new drugs;

• Pharmaceutical product certificate;

• Documentation of the national or foreign holder, and of the legal representative in Mexico:

  • Local sanitary license;

  • Power of attorney from the holder to the legal representative in Mexico;

  • Registration holder medicine manufacturer operating license;

  • Pharmacovigilance unit in Mexico.

The Agreement includes a detailed list of all documents that make up each of the items described above.

COFEPRIS must issue its opinion within 60 working days, starting from the day following the registration request day. If there is no manifestation within this period, it must be understood that the opinion is negative.

The requirements will be issued within 20 working days for administrative data and 40 working days for technical aspects. The revision period is suspended pending the response from the marketing authorization holder and if the marketing authorization used as a reference is canceled or suspended, the registration holder must notify COFEPRIS within 5 working days.

If there is a need to import a product without marketing authorization, it must be authorized by the authorities mentioned in the Agreement, and the registration process must be initiated in Mexico within five business days after importation. Importation without marketing authorization can only be done once and all imported batches will be analyzed by COFEPRIS Analytical Control and Expansion Commission (Comisión de Control Analítica y Ampliación de Cobertura).

It should be noted that, among the authorities recognized by PAHO through the WHO program, is the Agência Nacional de Vigilância Sanitária – ANVISA in Brazil.

The Agreement entered into force on the date of its publication, and can be accessed at the Official Gazette, through the link: https://bit.ly/3aWlp6R.

According to COFEPRIS, the measure has an important role in complying with the National Development Plan and the National Health Plan 2019 – 2024, ensuring the timely supply of medicines in the country.

The safety and quality aspects will be assured by the Commission through the items defined in the Agreement, such as the mandatory analysis of all lots by the COFEPRIS laboratory, the fact that marketing authorizations are already approved by high vigilance regulatory authorities and already used by the population in the countries of origin, the obligation to start the registration of imported products without registration before being used in the Mexican population, and the maintenance of pharmacovigilance in the country.

The note issued by COFEPRIS can be accessed at: https://bit.ly/36R4gsg.

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* “Acuerdo por el que se reconocen como equivalentes los requisitos establecidos en los artículos 161 Bis, 167, 169, 170 y 177 del Reglamento de Insumos para la Salud y a los procedimientos de evaluación técnica realizados por la Comisión Federal para la Protección contra Riesgos Sanitarios para el otorgamiento del registro sanitario de los insumos para la salud a que se refieren los artículos 2o., fracciones XIV, XV, incisos b y c y 166, fracciones I, II y III del Reglamento de Insumos para la Salud; en relación con los artículos 222 y 229 de la Ley General de Salud, los requisitos solicitados y procedimientos de evaluación realizados; así como la importación de medicamentos con o sin registro sanitario en México, dirigido a cualquier enfermedad o padecimiento, que estén autorizados por las siguientes autoridades reguladoras: Agencia Suiza para Productos Terapéuticos-Swissmed, Comisión Europea, Administración de Alimentos y Medicamentos de los Estados Unidos de América, Ministerio de Salud de Canadá, Administración de Productos Terapéuticos de Australia, Agencias Reguladoras de Referencia OPS/OMS; precalificados por el Programa de Precalificación para Medicamentos y Vacunas de la Organización Mundial de la Salud o Agencias Reguladoras miembros del Esquema de Cooperación de Inspección Farmacéutica.”